SmartMonitor 2PSL w/ Modem 1028970

GUDID B0361028970

SmartMonitor 2PSL w/ Modem

CIRCADIANCE, LLC

Infant apnoea monitor
Primary Device IDB0361028970
NIH Device Record Key06221142-49fc-49ef-82f3-d62333cd1527
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartMonitor 2PSL w/ Modem
Version Model Number1028970
Catalog Number1028970
Company DUNS012721295
Company NameCIRCADIANCE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-825-9640
Emailinfo@circadiance.com
Phone1-888-825-9640
Emailinfo@circadiance.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Battery Charge Temperature: 10ºC to 35ºC
Handling Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Battery Charge Temperature: 10ºC to 35ºC

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0361028970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPFMonitor, Apnea, Home Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-12-07

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